The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

Device Description

The Veloxion System consists of the following components: Veloxion Controller (with Integrated Fluid Control) with Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. The system also includes Class I accessories for handling waste: Waste Management Tubing and Tissue Catch. The system provides bipolar resection and coagulation of prostate adenomas, distends the cavity by filling with saline, and provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.

AI/ML Overview

This 510(k) summary for the Veloxion System (K190099) does not include a detailed study with acceptance criteria and reported device performance in the format of a table, nor does it provide a multi-reader multi-case comparative effectiveness study or details on standalone algorithm performance.

However, based on the provided text, here's an attempt to outline the acceptance criteria and study information where available, focusing on what can be inferred or directly stated.

Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance. Instead, it lists various non-clinical tests performed to demonstrate safety and effectiveness and substantial equivalence to a predicate device. The general acceptance criterion implied across all these tests is that the subject device performs as safely and effectively as the predicate device, or meets relevant industry standards.

Here's a summary of the performance claims based on the non-clinical testing data:

Acceptance Criterion (Implied)	Reported Device Performance (Summary from text)
System Integrity (withstanding operating pressures)	"System withstands operating pressures"
Functional Performance (Cut, Coagulation, Aspiration, Irrigation, Pressure Control)	"Cut and coagulation, aspiration, irrigation, pressure control" functions are met. Specific programmed flow rates are detailed (e.g., Steady State = 50ml/min, Cut = 380ml/min, Coag = 50ml/min, ASPIRATE = 400ml/min), and the device is able to set cavity pressure (20 to 60mmHg) and monitor saline. Over-pressure detection and mitigation (maximum 75mmHg, non-defeatable notification) are present.
Dimensional Accuracy	"Dimensional Inspection and Testing" performed, with Max. Shaft OD (Sheath) of 25Fr (8.3mm) and Working Length of 220mm, which are comparable to the predicate (26Fr, 193mm).
Thermal Performance (LED Tip Temperature)	"Maximum LED Tip Temperature" testing performed.
Visualization Performance	"Comparative visualization testing in a simulated model" performed. The device includes an "Integrated, Sterile, 10degree Endoscope," differing from the predicate's reusable 30° endoscope, but presumably demonstrating equivalent visualization quality.
Simulated Use Performance (Tissue resection, spot coagulation, cavity pressure, imaging)	"Simulated Use: Tissue resection and spot coagulation of cavity pressure, imaging" performed.
Durability (Electrode)	"Durability Testing: Electrode durability testing for tissue resection and coagulation." "Comparative testing to predicate for electrode durability." (Conclusion implies equivalence).
Biocompatibility	"Biocompatibility Testing: In accordance with ISO 10993-1" (Indicates compliance with the standard).
Sterility	"Sterility: In accordance with ISO 11135:2014, ISO 11137-1:2006, ISO 11137-2:2013" (Indicates compliance with the standards, device supplied sterile, single use).
Packaging Integrity	"Packaging: In accordance with ASTM D4169:14 and ISO 11607-1:2006" (Indicates compliance with the standards).
Shelf-life	"Shelf-life: In accordance with ASTM F1980:2007" (Indicates compliance with the standard).
Electrical Safety & EMC	"Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009" (Indicates compliance with the standards).
Usability	"Usability Testing: Use related risk evaluation" performed.
Software Performance	"Software Verification and Validation Testing performed per IEC 62304 and documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" (Indicates compliance with software standards and guidance).

Here's the additional information requested, based on the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the non-clinical tests.
The data provenance (country of origin, retrospective/prospective) is not provided. All tests listed are non-clinical, implying laboratory or simulated environments, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. No clinical studies are described, therefore "ground truth" in the clinical sense (e.g., from expert diagnoses) is not applicable here. The "ground truth" for the non-clinical tests would be the established engineering and medical standards and functional specifications that the device is tested against.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable to the non-clinical testing described. Adjudication methods are typically associated with clinical studies involving human observers or diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an active medical device (resectoscope system) for prostate adenoma resection, not an AI-powered diagnostic or assistive tool for image interpretation by human radiologists/clinicians in the sense that MRMC studies typically evaluate. The "visualization testing in a simulated model" is the closest mentioned, but it's not an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is not an algorithm or AI system in the typical standalone sense. It's a surgical system with integrated software and controls. While software verification and validation were performed (per IEC 62304), this refers to the performance of the integrated software controlling the device's functions, not a standalone AI algorithm producing diagnostic or predictive outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" would be objective measurements against established technical specifications, engineering principles, and relevant international and national standards (e.g., ISO, IEC, ASTM standards mentioned in the text). For fluid flow, pressure control, temperature, electrical safety, durability, and biocompatibility, the ground truth is the scientific and engineering benchmarks and standards themselves. For "simulated use" and "comparative visualization," the "ground truth" would involve demonstrating the device's ability to achieve its intended function effectively within the simulated environment, comparable to the predicate.

8. The sample size for the training set

This information is not applicable. The Veloxion System is a physical medical device with integrated software for control, not a machine learning or AI model that requires a "training set" to learn from data.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Summary

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March 15, 2019

Corinth MedTech, Inc. Sandeep Saboo Vice President, Quality Assurance and Regulatory Affairs 1601 S. De Anza Blvd, Suite 200 Cupertino, CA 95014

Re: K190099

Trade/Device Name: Veloxion System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FJL, KQT, GEI Dated: January 18, 2019 Received: January 22, 2019

Dear Sandeep Saboo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark R. Kreitz -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190099

Device Name Veloxion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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K190099: 510(k) Summary

I. Submitter Information

Submitter name:	Corinth MedTech, Inc.1601 S. De Anza Blvd, Suite 200Cupertino, CA 95014
Contact person:	Sandeep SabooVice President, Regulatory Affairs and Quality AssurancePhone: (408) 996-2517Fax: (408) 996-0621
Date Prepared:	06 March 2019

II. Product Classification

Device Name:	Veloxion System
Common Name:	Resectoscope	Subject Device
Regulation:	21 CFR 876.1500
Regulation Name:	Endoscope and accessories
Class:	II
Product Code:	FJL
Additional Product Codes:	KQT, GEI

III. Predicate Devices

The predicate device is the system comprised of the following legally marketed devices as used in combination to which substantial equivalence is claimed: Primary Predicate: Veloxion System (cleared per K162979)

Predicate has not been a subject of a design related recall.

IV. Device Description

The Veloxion System consists of the following components:

· Veloxion Controller (with Integrated Fluid Control)
- o Footswitch
· Veloxion Resectoscope
· Veloxion Fluid Control Set
· Veloxion Video Control Unit
· Veloxion Roll Stand

The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:

· Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
· Tissue Catch: For collection of gross resected tissue pieces for pathology.

The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing

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with the integrated Resectoscope. The components of Veloxion System perform the following functions:

The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
· The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
· The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
· The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
· The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag.

V. Indications for Use

There is no difference in the indications for use for the subject device when compared to the predicate device

Device	Indications For Use
Modified VeloxionSystem(Subject Device)	The Veloxion System is intended for use by trained urologists forendoscopically controlled tissue chip resection and coagulation, andremoval of prostate adenomas via suction channel under continuous flowconditions following resection using a bipolar resecting device.
Veloxion SystemK162979(Predicate Device)	The Veloxion System is intended for endoscopically controlled tissue chipresection and coagulation and removal of prostate adenomas via suctionchannel under continuous flow conditions following resection using abipolar resecting device.

Comparison of Indications for Use

VI. Comparison of Technological Characteristics with the Predicate Device

The subject Veloxion System and the previously cleared Veloxion System (K162979) have the same or similar technological characteristics in terms of basic operating principle and basic design features with one key difference being that the subject Veloxion System includes a sterile, single use camera and light while the predicate Veloxion System uses a commercially available reusable Endoscope.

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Veloxion System Traditional 510(k) Premarket Notification

Technological Characteristics	Modified VELOXION SYSTEM(Subject)	VELOXION SYSTEM(Predicate K162979)
Monopolar or Bipolar	Bipolar	Bipolar
Energy Type:	Radiofrequency, Bipolar	Radiofrequency, Bipolar
Optics:	Integrated, Sterile, 10degree Endoscope	Compatible with reusable 30° marketed Endoscope
Able to Set Cavity Pressure on the Device?	YES	YES
Continuous Flow? :	YES	YES
Irrigation fluid:	Saline	Saline
Pump?	Dual Pump (Irrigation, Aspiration)	Dual Pump (Irrigation, Aspiration)
Able to Monitor saline remaining?:	YES	YES
Programmed Flow Rate:	Programmed flow rate constant for each mode:Steady State = 50ml/min,Cut = 380ml/minCoag = 50ml/minASPIRATE = 400ml/min	Programmed flow rate constant for each mode:Steady State = 100ml/min,Cut = 380ml/min,Coag = 100ml/minASPIRATE = 750ml/min
Passive Flow:	User adjustable flow rate using Roller Clamp installed duringmanufacturing. The nominal passive flow rate when Roller Clampis fully open is:• 360ml/min (at 20mmHg)• 500ml/min (at 60mmHg)	No passive flow
Set Pressure Range:	20 to 60mmHg	10 to 60mmHg
Positive Action to Increase Above 40mmHg:	YES	YES
Pressure Sensor:	Dual, independent, direct sensing of cavity pressure	Dual, independent, direct sensing of cavity pressure
Over-pressure condition detection:	YES	YES
Maximum Allowable Actual Cavity Pressure	75mmHg	75mmHg
Ultimate mitigation for risk of over-pressurization ofcavity if all designed mitigations are unsuccessful	• Non-defeatable, continuous notification tone• Notification displayed:"Remove device from cavity. Check for Clog."	• Notification tone• Notification displayed:"Remove device from cavity. Check for Clog."
Max. Shaft OD (Sheath):	With Sheath Assembled: 25Fr (8.3mm)	With Sheath Assembled: 26Fr (8.6mm)
Working Length:	Sheath Working Length: 220mm	Sheath Working Length: 193mm
Materials (Electrode/ Insulation):	Electrode: Tungsten (99.95% purity)Insulation: FEP	Electrode: Tungsten (99.95% purity)Insulation: FEP
How Supplied (Sterility):	Sterile, Single Use(Veloxion Resectoscope)	Sterile, Single Use(Veloxion Resecting Device Kit)

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K190099

The main technological differences between the subject Veloxion System and the predicate Veloxion System are the following:

The subject Veloxion System includes a sterile, single-use camera and light system while the predicate Veloxion System uses a commercially available reusable Endoscope.
The subject Veloxion System includes programmed flow rates that are slightly different than the predicate Veloxion System as a result of an integrated passive flow mechanism.

The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the subject Veloxion System.

VII. Non-Clinical Testing Data

The following performance data have been provided in support of the substantial equivalence determination.

Software Verification and Validation Testing performed per IEC 62304 and . documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Other Tests were performed per approved test protocols which included: ●
- o Integrity: System withstands operating pressures
  - Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control O
  - Dimensional Inspection and Testing O
  - Functional Testing for all components of the system O
  - Maximum LED Tip Temperature O
  - Comparative visualization testing in a simulated model O
  - Simulated Use: Tissue resection and spot coagulation of cavity pressure, O imaging
  - Durability Testing: Electrode durability testing for tissue resection and coagulation. O
  - Comparative testing to predicate for electrode durability, pressure control and fluid O control.
  - Thermal effects evaluation. O
  - Biocompatibility Testing: In accordance with ISO 10993-1 O
  - Sterility: In accordance with ISO 11135:2014, ISO 11137-1:2006, ISO 11137-2:2013 O
  - Packaging: In accordance with ASTM D4169:14 and ISO 11607-1:2006. O
  - Shelf-life: In accordance with ASTM F1980:2007. O
  - Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-O 2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009.
  - Usability Testing: Use related risk evaluation o

VIII. Conclusions

Based on the results of performance tests, the subject Veloxion System is considered to be substantially equivalent and as safe and effective as the predicate Veloxion System (K162979).

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.